Matrixx considering partnership with other OTC companies to release Zicare and Xcid
SCOTTSDALE, Ariz. Matrixx Initiatives is exploring partnering with other over-the-counter companies on the national roll out of its Zicare oral care product and Xcid antacid.
“We continue to explore the possibility of partnering with other parties on both of those projects,,” Bill Hemelt, Matrixx acting president, CFO and COO, told analysts last week. “As we’ve said before, we don’t want to move forward on them by ourselves because of the significant risks associated with that,” he said. “Xcid was a disappointment. … We did roll it out on a limited basis this past year, but it did not meet our expectations. Not because it’s a bad product, it just simply will require greater investment to take that nationally. So we are exploring partnership possibilities for both of those projects.”
Both products are “market ready,” Hemelt said, replete with consumer research and product research.
Zicare, when used in conjunction with a daily oral routine, helps dissolve up to 30% of visible tartar that has already formed and helps inhibit future tartar formation above the gumline, according to the product web site. Zicare is a gel that is applied at the gumline and between the teeth after brushing and before bed.
Xcid is an antacid featuring a unique delivery form — a creamy pudding-like gel available in three flavors: strawberry, orange and chocolate.
CRA urges supplement and food companies to keep record of dietary supplement ingredients
WASHINGTON Responding to a recent Food and Drug Administration decision that defines pyridoxamine dihydrochloride, a form of vitamin B6, as a new drug, the Council for Responsible Nutrition reiterated its position that vitamin B6 has a long history sold as a dietary supplement.
“FDA’s decision suggests that companies need to produce even more extensive evidence supporting an ingredient’s marketing as a dietary supplement, including catalog and business records from more than 15 years ago,” stated Andrew Shao, CRN’s VP scientific and regulatory affairs. “Demanding that industry maintain these records, but failing to work with industry to develop an agreed-upon list of ‘grandfathered ingredients,’ places more burden on dietary supplement companies to be sure that they can substantiate that an ingredient has in fact previously been marketed as a dietary supplement.”
The FDA’s decision precludes any dietary supplement manufacturer from marketing pyridoxamine without first obtaining FDA approval through a new drug application. CRN has argued that pyridoxamine has been on the market as a supplement even prior to the passing of the Dietary Supplement Health and Education Act. Under DSHEA provisions, an ingredient that has been sold as a supplement prior to being submitted as a new drug can continue to be sold as a supplement. Conversely, an ingredient cannot be marketed as a supplement following the submission of an NDA.
“The Agency’s decision on pyridoxamine could set a precedent for the status of other dietary ingredients to be challenged,” Shao suggested. “As such, CRN strongly encourages supplement and food companies to keep careful records of ingredients and marketing materials to ensure that the ingredients that they are using and marketing can continue to be marketed as dietary supplement ingredients under the law.”
Reps. introduce FDA Globalization Act of 2009 to earmark funding against increased inspections of int’l food and drug facilities
WASHINGTON In an effort to better safeguard America’s food and drug supply, Reps. John Dingell, D-Mich., Frank Pallone Jr., D-N.J., and Bart Stupak, D-Mich., on Wednesday introduced the Food and Drug Administration Globalization Act of 2009, a piece of legislation that would earmark funding specifically against increased inspections of international food and drug facilities and improve information systems.
The legislation also would require food producers to have preventive food safety plans in place and subjects the plans to FDA inspection; require food imports to meet all U.S. standards; would close the loopholes in the FDA’s ability to trace the source of contaminated products; and would impose stiff penalties on companies that violate safety standards, according to a press release issued announcing introduction of the legislation.
“Antiquated authorities and years of starving the FDA of resources has put the public health at risk,” stated Dingell. “Every few months brings another crisis — E. Coli in spinach, contaminated heparin, tainted peppers and now salmonella in peanut butter — that has killed eight people and sickened more than 483 people. The time to act is now,” he said. “Americans shouldn’t have to worry about whether the food they serve their families and the medical products they use to improve their health might actually make them sick.”
“As witnessed by the latest salmonella outbreak, the Peanut Corp. of America’s outrageous actions show that food manufacturers cannot be trusted to self-regulate,” Pallone charged.